510(k) K861575 ยท GTY Antigens, All Groups, Streptococcus Spp.
DIRECTATEX STREP A
| Applicant | Pacific Biotech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 3, 1986 |
| Received | Apr 28, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861575
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.